Irreversible PulpitisPhase 2NCT01572116
Effect of Sufentanil on the Rate of Anesthesia
A Phase 2 study testing Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + sufentanil in people with Irreversible Pulpitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients in the age group of 18-65 years old
- healthy (ASA I, II)
- patients with first or second mandibular molars who need endodontic treatment
- vital tooth without a history of past endodontic treatment
- patients with clinical evidence of irreversible Pulpits with moderate to severe pain
- patients who signed consent form
- patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.
Who cannot join
- pregnant or nursing
- necrotic tooth
- patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
- Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
- patient with infectious diseases
- patient with moderate to sever periodontal disease
- those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis
The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.
- Conditions
- Irreversible Pulpitis
- Being tested
- Lidocaine with Epinephrine+ Normal saline, Lidocaine with Epinephrine + sufentanil
- Keywords
- sufentanil, irreversible pulpitis, intra ligament injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine with Epinephrine+ Normal salineDrug
PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
Lidocaine with Epinephrine + sufentanilDrug
Also called Brand name:Sufenta
PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine with Epinephrine+ Normal saline | Placebo comparator | Not described Receives: Drug: Lidocaine with Epinephrine+ Normal saline |
| Lidocaine with Epinephrine + sufentanil | Active comparator | Not described Receives: Drug: Lidocaine with Epinephrine + sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of anesthesia
The measuring method of the pain is Electric pulp tester
Measured: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment
Secondary outcomes (1)
intensity of the pain
The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)
Measured: before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandana Abedi Tari, Islamic Azad University, Sanandaj
- Investigators
- Mandana Abedi Tari, Dentist, Principal investigator, Dental School of Azad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572116
- Sponsor's protocol ID
- IRCT201110137790N1
- Status last verified
- Apr 2012
- First submitted
- 3 Mar 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01572116
- Acronym / sponsor ID
- IRCT201110137790N1
- Conditions
- Irreversible Pulpitis
- Keywords
- sufentanil, irreversible pulpitis, intra ligament injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine with Epinephrine+ Normal saline | Placebo comparator | Drug: Lidocaine with Epinephrine+ Normal saline |
| Lidocaine with Epinephrine + sufentanil | Active comparator | Drug: Lidocaine with Epinephrine + sufentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients in the age group of 18-65 years old
- healthy (ASA I, II)
- patients with first or second mandibular molars who need endodontic treatment
- vital tooth without a history of past endodontic treatment
- patients with clinical evidence of irreversible Pulpits with moderate to severe pain
Key exclusion criteria (7 listed)
- pregnant or nursing
- necrotic tooth
- patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
- Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
- patient with infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine with Epinephrine+ Normal salinePDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline | Drug | Lidocaine with Epinephrine+ Normal saline |
| Lidocaine with Epinephrine + sufentanilAlso: Brand name:SufentaPDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg) | Drug | Lidocaine with Epinephrine + sufentanil |
Primary outcome
depth of anesthesia
Time frame: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment
The measuring method of the pain is Electric pulp tester
1 secondary outcome
intensity of the pain
Time frame: before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandana Abedi Tari, Dentist principal investigator
Dental School of Azad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + sufentanil in people with Irreversible Pulpitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of anesthesia (time frame: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012; AzTrials last refreshed its copy on 26 Oct 2026.